Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis

Last updated: September 10, 2025
Sponsor: Nantes University Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Dermatitis, Atopic

Atopic Dermatitis

Rash

Treatment

Dupilumab step-down

Clinical Study ID

NCT05642208
RC22_0378
  • Ages > 12
  • All Genders

Study Summary

The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 12 years

  • Moderate to severe AD treated with dupilumab every 2 weeks

  • Written informed consent (patient and/or person who has parental authority)

  • Dupilumab treatment for at least one year

  • Controlled AD (ADCT<7 and IGA ≤ 2) and assessed as controlled by the investigatorsince at least 6 months without tapering dosage of dupilumab

  • Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months andless than 60 g/month

Exclusion

Exclusion Criteria:

  • Patients with Side effects of dupilumab

  • Non controlled AD: ADCT ≥ 7 or IGA ≥ 3

  • Female patient must not be pregnant*, breastfeeding or considering becoming pregnant

  • Patient under judicial protection

  • Adults under guardianship or trusteeship

Study Design

Total Participants: 256
Treatment Group(s): 1
Primary Treatment: Dupilumab step-down
Phase: 4
Study Start date:
March 08, 2023
Estimated Completion Date:
September 08, 2026

Study Description

For both groups:

At inclusion visit :

  • Patient information and signature of consent form

  • Randomisation

  • Previous medical history

  • Clinical exam

  • Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L

Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) :

  • Self-assessment of ADCT

  • Date of dupilumab injections

  • Batch number of dupilumab

  • Amount of topical corticosteroids

Visits at M4, M8 and M12 will be performed for :

  • Clinical exam

  • Recording secondary end points (EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L) and adverse events

  • Collect out-of-pocket expenses (M4 and M12).

Connect with a study center

  • Amiens University hospital

    Amiens,
    France

    Site Not Available

  • Amiens University hospital

    Amiens 3037854,
    France

    Site Not Available

  • CHU d'Angers

    Angers,
    France

    Site Not Available

  • CHU d'Angers

    Angers 3037656,
    France

    Site Not Available

  • Hôpital Victor Dupouy

    Argenteuil,
    France

    Site Not Available

  • Hôpital Victor Dupouy

    Argenteuil 3037044,
    France

    Site Not Available

  • CHU de Besançon

    Besançon,
    France

    Site Not Available

  • CHU de Besançon

    Besançon 3033123,
    France

    Site Not Available

  • CHU de Bordeaux Adulte

    Bordeaux,
    France

    Site Not Available

  • CHU de Bordeaux Adulte

    Bordeaux 3031582,
    France

    Site Not Available

  • CHRU de Brest

    Brest,
    France

    Site Not Available

  • CHRU de Brest

    Brest 3030300,
    France

    Site Not Available

  • CHU de Clermont Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • CHU de Clermont Ferrand

    Clermont-Ferrand 3024635,
    France

    Site Not Available

  • CHU de Dijon

    Dijon,
    France

    Site Not Available

  • CHU de Dijon

    Dijon 3021372,
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble,
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble 3014728,
    France

    Site Not Available

  • CHD Vendée

    La Roche-sur-Yon,
    France

    Site Not Available

  • CHD Vendée

    La Roche-sur-Yon 3006767,
    France

    Site Not Available

  • GH La Rochelle - Ré-Aunis

    La Rochelle,
    France

    Site Not Available

  • GH La Rochelle - Ré-Aunis

    La Rochelle 3006787,
    France

    Site Not Available

  • CH de Le Mans

    Le Mans,
    France

    Site Not Available

  • CH de Le Mans

    Le Mans 3003603,
    France

    Site Not Available

  • CHRU de Lille

    Lille,
    France

    Site Not Available

  • Groupement des Hôpitaux de l'institut Catholique de Lille

    Lille,
    France

    Terminated

  • CHRU de Lille

    Lille 2998324,
    France

    Site Not Available

  • Groupement des Hôpitaux de l'institut Catholique de Lille

    Lille 2998324,
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon,
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon 2996944,
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille,
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille 2995469,
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier,
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier 2992166,
    France

    Site Not Available

  • CHU de Nantes

    Nantes,
    France

    Site Not Available

  • CHU de Nantes

    Nantes 2990969,
    France

    Site Not Available

  • CH de Niort

    Niort,
    France

    Site Not Available

  • CH de Niort

    Niort 2990355,
    France

    Site Not Available

  • Hôpital Cochin

    Paris,
    France

    Site Not Available

  • Hôpital Necker-Enfants malades

    Paris,
    France

    Active - Recruiting

  • Hôpital Saint Louis

    Paris,
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris,
    France

    Active - Recruiting

  • Hôpital Cochin

    Paris 2988507,
    France

    Site Not Available

  • Hôpital Necker-Enfants malades

    Paris 2988507,
    France

    Site Not Available

  • Hôpital Saint Louis

    Paris 2988507,
    France

    Site Not Available

  • Hôpital Tenon

    Paris 2988507,
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers,
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers 2986495,
    France

    Site Not Available

  • CHU de Reims

    Reims,
    France

    Site Not Available

  • CHU de Reims

    Reims 2984114,
    France

    Site Not Available

  • CHU de Rennes

    Rennes,
    France

    Site Not Available

  • CHU de Rennes

    Rennes 2983990,
    France

    Site Not Available

  • CHU de Rouen

    Rouen,
    France

    Site Not Available

  • CHU de Rouen

    Rouen 2982652,
    France

    Site Not Available

  • CH de Saint Nazaire

    Saint-Nazaire,
    France

    Site Not Available

  • CH de Saint Nazaire

    Saint-Nazaire 2977921,
    France

    Site Not Available

  • HIA Sainte Anne

    Toulon,
    France

    Site Not Available

  • HIA Sainte Anne

    Toulon 2972328,
    France

    Site Not Available

  • CHU de Toulouse - Hôpital Larrey

    Toulouse,
    France

    Site Not Available

  • CHU de Toulouse - Hôpital Larrey

    Toulouse 2972315,
    France

    Site Not Available

  • CHRU de Tours

    Tours,
    France

    Site Not Available

  • CHRU de Tours

    Tours 2972191,
    France

    Site Not Available

  • CHU de La Réunion

    Saint-Pierre 935214, La Réunion
    Reunion

    Site Not Available

  • CHU de La Réunion

    Saint-Pierre, La Réunion
    Réunion

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.